What the FDA labels say about taking them together
Flumazenil and midazolam
Midazolam's FDA label of January 1, 2024 names flumazenil in its warnings section; flumazenil's label does not name midazolam itself but warns about its class (Benzodiazepines). The midazolam label: “… discontinuation or rapid dosage reduction of NAYZILAM, or administration of flumazenil may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures).”
Check it at the source: the flumazenil FDA label on DailyMed (effective June 21, 2024, Hikma Pharmaceuticals USA Inc.); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).
What does the flumazenil label say about midazolam?
Flumazenil's label does not name midazolam itself; it warns about its class (Benzodiazepines):
Flumazenil label, contraindicationsCONTRAINDICATIONS Flumazenil is contraindicated: in patients with a known hypersensitivity to flumazenil or benzodiazepines. in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus). in patients who are showing signs of serious cyclic antidepressant overdose (see WARNINGS ).
Flumazenil label, boxed warningTHESE ARE MOST FREQUENT IN PATIENTS WHO HAVE BEEN ON BENZODIAZEPINES FOR LONG-TERM SEDATION OR IN OVERDOSE CASES WHERE PATIENTS ARE SHOWING SIGNS OF SERIOUS CYCLIC ANTIDEPRESSANT OVERDOSE.
Source: FDA drug label (Flumazenil), Hikma Pharmaceuticals USA Inc., effective June 21, 2024 (SPL set 436f5616-9626-4b6a-9deb-2986444179d0), via openFDA; the full label on DailyMed
What does the midazolam label say about flumazenil?
Midazolam label, warningsThe immediate availability of specific reversal agents (flumazenil) is highly recommended.
N/A label (Rafa Laboratories, Ltd., February 18, 2026), warnings and precautionsAlthough Midazolam Injection is indicated only for intermittent use [see Indications and Usage (1) and Dosage and Administration (2)], if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of Midazolam Injection, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence (9.3)].
Midazolam In Sodium Chloride label (WG Critical Care, LLC., July 31, 2025), warnings and precautionsA benzodiazepine reversal agent (i.e., flumazenil) should be immediately available during administration of Midazolam in 0.9% Sodium Chloride Injection.
Source: FDA drug label (N/A, NDA216359), Rafa Laboratories, Ltd., effective February 18, 2026 (SPL set d7362b4d-68a3-99a0-e053-2995a90a4f60), via openFDA
Source: FDA drug label (Nayzilam, NDA211321), UCB, Inc., effective January 19, 2023 (SPL set 2b29422e-54d5-4a49-8522-e9cf752368c3), via openFDA
Source: FDA drug label (Midazolam In Sodium Chloride, NDA211844), WG Critical Care, LLC., effective July 31, 2025 (SPL set f051776f-94c5-4e34-80ed-f45b9c36881e), via openFDA
Source: FDA drug label (Midazolam), Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Flumazenil | Midazolam | |
|---|---|---|
| Labeled for | n/a | n/a |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $1.18 per mL 0.5 mg/5 mL vial | $0.233 per mL 2 mg/2 mL vial |
| Shortage now | No current entry | In shortage |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once